The FDA decided to require approval of new drug applications (NDAs) for all pancreatic extract drug products after reviewing data that showed substantial variations among currently marketed products.
They found that variations in the formulation, dosage, and manufacturing processes affected the potency of the enzymes after patients take them. The resulting variations in drug potency could significantly affect the safety and effectiveness of the drugs.
“Variations in the potency of pancreatic extract drug product are unacceptable".
|There are more than 36 different products on the market.|
"Patients with exocrine pancreatic insufficiency disorders rely on these drugs to provide the enzymes they need to digest food properly".
"If the label contains an inaccurate statement about a particular product’s potency, then the patient is at risk for receiving too much or too little of the medicine,” said Dr Lester Crawford, Acting Commissioner of Food and Drugs.
Dr Steven Galson, Center for Drug Evaluation and Research, stated, “By requiring manufacturers to get approval for their pancreatic extract drug products, the FDA will be better able to ensure the safety and effectiveness of these products.”
Pancreatic extract products have a long history of use, some preceding the Federal Food, Drug, and Cosmetic Act of 1938.
There are more than 36 different products are being marketed. Only 1 has received formal FDA approval but this is no longer marketed.
The other products continue to be available because of their established use as replacement therapy to treat serious conditions associated with pancreatic insufficiency, including chronic pancreatitis and cystic fibrosis.
An added benefit of requiring FDA approval for pancreatic extract drug products is that the resulting standardization of the enzyme extract will lead to more accurate product labels, providing better information to patients and healthcare professionals.
The FDA’s notice covers pancreatic extract preparations containing pancreatin and pancrealipase.